Bicyclol (DB16014): A Comprehensive Pharmacological and Clinical Report

1. Introduction to Bicyclol

1.1. Overview, Origin, and Significance

Bicyclol, identified by DrugBank Accession Number DB16014, is a synthetic small molecule pharmaceutical agent.[1] It originates from a lignan component of Schisandra chinensis (Wuweizi), a medicinal herb with a long history of use in traditional Chinese medicine (TCM). Specifically, Bicyclol is a synthetic derivative of Schisandrin C, one of the dibenzocyclooctadiene lignans found in the fruit of Schisandra chinensis.[3] This derivation represents a notable example of drug development that bridges traditional medicinal knowledge with modern synthetic chemistry and rigorous pharmacological evaluation.

The primary therapeutic application of Bicyclol lies in its significant hepatoprotective properties. It has been extensively utilized in clinical practice in China for the management of a variety of liver disorders.[3] Its designation as an "innovative chemical drug with proprietary intellectual property rights in China" [4] underscores its importance within the national pharmaceutical landscape and its contribution to addressing the burden of liver diseases.

A key area of contemporary clinical investigation for Bicyclol is its efficacy in the treatment of acute drug-induced liver injury (DILI). It is the subject of a significant clinical trial, registered as NCT02944552 and titled "The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatment of Acute DILI".[2] The outcomes of this trial are pivotal in establishing an evidence-based role for Bicyclol in this specific and challenging clinical indication.